100 Participants Needed

Sleep and Light Therapy for Circadian Rhythm Disorder

(CARRS-P2 Trial)

MW
RG
Overseen ByRonette G Blake, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times. Many studies find that this increases the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 2 (P2) of the CARRS center will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those who have changed their psychotropic medications in the 2 weeks before joining or plan major changes during the study. It also excludes those on medications that increase sensitivity to blue light.

What data supports the effectiveness of the treatment 'Sleep and Light Therapy for Circadian Rhythm Disorder'?

Research shows that light therapy, which is part of this treatment, can improve sleep quality and timing in people with circadian rhythm disorders and certain psychiatric conditions. Additionally, studies on similar therapies, like triple chronotherapy, have shown rapid improvements in mood and sleep patterns, suggesting potential benefits for managing circadian rhythm disorders.12345

Is light therapy safe for treating circadian rhythm disorders?

Research indicates that light therapy, including morning bright light and blue light-blocking glasses, is generally well tolerated and safe for improving sleep and mood in various conditions, such as sleep deprivation and mood disorders.678910

How does sleep and light therapy differ from other treatments for circadian rhythm disorder?

Sleep and light therapy is unique because it uses controlled exposure to light and darkness to adjust the body's internal clock, which can improve sleep patterns and mood. Unlike medications, this treatment focuses on natural environmental cues to regulate circadian rhythms, making it a non-invasive option for managing sleep disorders.134711

Research Team

BH

Brant Hasler, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for healthy teens typically enrolled in high school, who go to bed later than 11:15 PM and are not homeschooled. They can't have metal in their body, be pregnant, have unstable medical conditions, recent changes to psychotropic meds, extreme late sleep patterns, frequent headaches or migraines, a history of substance use or serious psychiatric disorders.

Inclusion Criteria

I am enrolled in a traditional high school with live classes.
I am in good physical and mental health.
Provision of written informed consent and assent
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Exclusion Criteria

I do not have any severe or unstable health conditions.
You have a serious mental health condition, like depression or bipolar disorder, that could make it hard for you to finish the study.
You have used alcohol, cannabis, or illegal drugs in the past month, or more than once a month in the past year.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Participants undergo 2 weeks of home sleep monitoring followed by an overnight laboratory visit for assessments

2 weeks
1 overnight laboratory visit

Experimental Manipulation

Participants in the Late group undergo sleep and circadian rhythm manipulation for approximately 2 weeks

2 weeks
1 initial laboratory visit, followed by home-based intervention

Follow-up

Participants are monitored for changes in sleep and substance use every 6 months

6 months

Treatment Details

Interventions

  • Decrease evening blue light
  • Increase morning bright light
  • Monitor sleep, mood, and substance use
  • Sleep Scheduling
Trial Overview The study explores how manipulating sleep and circadian rhythms affects reward function in adolescents. It involves monitoring sleep patterns and mood while adjusting light exposure (more bright light in the morning; less blue light at night) and managing sleep schedules.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Advance/Extend ManipulationExperimental Treatment4 Interventions
For \~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to: * Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) * Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) * Increase morning bright light exposure via bright light goggles (30 min after rise) * Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Group II: ControlActive Control1 Intervention
Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

Chronotherapy, which includes strategies like light therapy and sleep deprivation, has been shown to effectively reduce depressive symptoms and improve recovery in patients with depression and bipolar disorder.
Recent research indicates that combining chronotherapeutic interventions with pharmacological treatments can enhance efficacy, leading to shorter hospital stays and fewer changes in medication prescriptions.
The effect of chronotherapy on depressive symptoms. Evidence-based practice.Khalifeh, AH.[2018]
In a pilot study of 44 unipolar depressed outpatients, triple chronotherapy showed a higher Week 1 remission rate (25.0%) compared to an alternative protocol (6.7%), although this difference was not statistically significant.
The study indicated that triple chronotherapy is feasible and well-tolerated in this population, suggesting the need for larger trials to better assess its efficacy in treating unipolar depression.
A randomized, controlled trial assessing the acute efficacy of triple chronotherapy in unipolar depression.Yuen, LD., Chen, Y., Stewart, JW., et al.[2022]
A meta-analysis of 40 studies found that light interventions significantly improve sleep quality and timing in individuals with circadian rhythm disorders and neuropsychiatric conditions, with notable effects on sleep continuity and self-reported disturbances.
Avoiding evening light exposure was linked to increased total sleep time, suggesting that light management could be a beneficial strategy for enhancing sleep in psychiatric populations, warranting further research and tailored interventions.
Light therapies to improve sleep in intrinsic circadian rhythm sleep disorders and neuro-psychiatric illness: A systematic review and meta-analysis.Faulkner, SM., Bee, PE., Meyer, N., et al.[2021]

References

The effect of chronotherapy on depressive symptoms. Evidence-based practice. [2018]
A randomized, controlled trial assessing the acute efficacy of triple chronotherapy in unipolar depression. [2022]
Light therapies to improve sleep in intrinsic circadian rhythm sleep disorders and neuro-psychiatric illness: A systematic review and meta-analysis. [2021]
Morningness-eveningness scores predict outcomes differentially for depressed patients attending morning vs. afternoon day treatment streams. [2020]
Adjunctive triple chronotherapy (combined total sleep deprivation, sleep phase advance, and bright light therapy) rapidly improves mood and suicidality in suicidal depressed inpatients: an open label pilot study. [2022]
Effect of Morning Light Glasses and Night Short-Wavelength Filter Glasses on Sleep-Wake Rhythmicity in Medical Inpatients. [2020]
Dark therapy for bipolar disorder using amber lenses for blue light blockade. [2022]
Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. [2021]
Changing color and intensity of LED lighting across the day impacts on circadian melatonin rhythms and sleep in healthy men. [2021]
Circadian genes, rhythms and the biology of mood disorders. [2022]
CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]